FDA Commissioner Issues Update on Drug Shortages in Puerto Rico

The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb has issued an update on the agency’s effort to support manufacturing in Puerto Rico following Hurricanes Irma and Maria, particularly regarding saline shortage. This follows an earlier update from November 2017 provided by Gottlieb.

Consistent with the November 2017 update, Gottlieb says in his January 4, 2018 statement that a key area of focus for the FDA remains addressing the IV saline shortage, which he says has impacted patients, healthcare providers, and hospitals.

“Based on the information we’re receiving from the companies, we expect that the shortage of IV saline fluids will improve in early 2018, with continuing improvements in the weeks ahead,” Gottlieb said in his January statement. “Just before the holidays, Baxter – a leading producer of IV saline fluids – announced that all [its] facilities on the island have returned to the commercial power grid.”

Gottlieb also said that other companies that manufacture products that were on the agency’s initial list of drugs that were considered critical and at risk of potential shortages,  because the drugs were largely or entirely manufactured in Puerto Rico, are now on the power grid. While the commercial power grid reportedly remains unstable in places, Gottlieb says these developments reduce the risk of any future shortages resulting from the impact of the storm on the island’s manufacturing sector.

Gottlieb says the return of power to all of Baxter’s facilities also means that the shortage situation for pediatric and adult formulations of IV amino acids is anticipated to continue to improve in the coming weeks. In his November 2017 update, Gottlieb pointed to the shortage of amino acids for injection used in nutritional formulations as another key focus for the FDA. In addition, one of the firms that previously manufactured IV amino acids, ICU Medical, is planning to return to the market early in 2018. Gottlieb says the FDA will continue to take all possible steps to continue to address this critical shortage.

“Given the improvements we’ve seen over the last few weeks, I’m optimistic that supplies of IV saline and amino acids will increase over the next few weeks and the stress of the shortage will begin to abate, even if the shortages will not be fully resolved immediately,” Gottlieb said in his latest statement. “That said, the production situation in Puerto Rico remains fragile. As many risks and challenges remain and there are still shortages affecting patient care, we’ll continue to take all possible steps to help improve shortage situations.”

Source: FDA

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